证券代码：688513 证券简称：苑东生物 公告编号：2025-060 成都苑东生物制药股份有限公司 关于自愿披露盐酸纳呋拉啡口崩片获得 药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 成都苑东生物制药股份有限公司（以下简称"公司"）于近日收到国家药品监 督管理局（以下简称"国家药监局"）核准签发的《药品注册证书》，现将相关 情况公告如下： 一、药品基本情况 药品名称：盐酸纳呋拉啡口崩片 剂型：片剂 药品有效期：18 个月 上市许可持有人：成都苑东生物制药股份有限公司 生产企业：成都苑东生物制药股份有限公司 药品注册标准编号：YBH20352025 受理号：CYHS2401764 证书编号：2025S02608 药品批准文号：国药准字 H20255225 规格：2.5 μg 注册分类：化学药品 4 类 根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品 1 注册的有关要求，批准注册，发给药品注册证书。质量标准、说明书、标签及 生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求 ...

Core Viewpoint - The company, Yuandong Biotech (688513), has received approval from the National Medical Products Administration for the drug registration certificate of hydrochloride nafurafine orally disintegrating tablets, indicating a significant advancement in its product pipeline [1] Company Summary - Yuandong Biotech has recently announced the approval of hydrochloride nafurafine orally disintegrating tablets, which are classified as a second-class psychotropic drug under national regulations [1] - The primary active ingredient, hydrochloride nafurafine, is indicated for the treatment of pruritus in patients undergoing hemodialysis, specifically for cases where existing treatments are ineffective [1]

Core Points - The 11th Jin Qilin Golden Secretary Honor List was announced on September 1, recognizing outstanding corporate secretaries in the industry [1] - Li Shuyun, the corporate secretary of Yuandong Bio, received the Responsibility Pioneer Award for her exceptional professional capabilities and performance [1][2] - The Jin Qilin awards have been held for eleven years, evaluating over 900 excellent corporate secretaries, and are recognized as a prestigious award in the industry [1] Summary by Categories Corporate Governance - Corporate secretaries play multiple roles in corporate governance, acting as gatekeepers for compliance and as advisors for capital strategy [1] - They are responsible for information disclosure and building investor relations, contributing to the overall governance and ESG (Environmental, Social, and Governance) efforts of the company [1] Recognition and Impact - The award reflects the market's and investors' high recognition of Yuandong Bio's governance level and value growth [2] - Li Shuyun exemplifies the qualities of an excellent corporate secretary, effectively communicating company value and demonstrating corporate responsibility [2]

Core Viewpoint - The article highlights the importance of company secretaries (董秘) as a crucial link between listed companies and the capital market, emphasizing their multifaceted roles in corporate governance and development [1]. Group 1: Roles of Company Secretaries - Company secretaries act as gatekeepers for corporate compliance and governance [1]. - They serve as advisors for capital strategy and are responsible for information disclosure [1]. - They also play a key role in building investor relations [1]. Group 2: Recognition of Outstanding Company Secretaries - A total of 73 company secretaries were recognized for their excellence in various key indicators such as information disclosure quality, corporate governance, and investment value [1]. - The recognition is part of the 11th Golden Unicorn Awards for outstanding company secretaries [1].

Company Overview - Yuan Dong Bio's stock price increased by 5.22% on September 1, reaching 68.95 CNY per share, with a trading volume of 1.07 billion CNY and a turnover rate of 0.92%, resulting in a total market capitalization of 12.172 billion CNY [1] - The company has experienced a cumulative increase of 3.88% over the past three days [1] - Founded on June 1, 2009, and listed on September 2, 2020, Yuan Dong Bio specializes in the research, production, and sales of chemical raw materials and chemical drug formulations [1] - The revenue composition of the company includes 78.75% from formulation sales, 9.22% from raw material sales, 6.79% from technical services and transfers, 4.01% from CMO/CDMO, and 1.22% from other sources [1] Fund Holdings - According to data, one fund under Industrial Bank, the Xingye Healthcare A Fund (011466), holds a significant position in Yuan Dong Bio, with 699,200 shares, accounting for 7.46% of the fund's net value, making it the largest holding [2] - The fund has realized a floating profit of approximately 2.3913 million CNY today, with a floating profit of 1.7131 million CNY during the three-day increase [2] - Xingye Healthcare A Fund was established on March 8, 2021, with a current scale of 249 million CNY, achieving a year-to-date return of 33.5% and a one-year return of 41.06% [2]

Group 1 - The A-share market's innovative drug concept stocks have experienced a collective decline for the third consecutive day, with notable drops including Nanjing New Pharmaceutical falling over 11% and Yuandong Bio down over 9% [2] - Other companies such as Borui Pharmaceutical, Zhaoyan New Drug, and Kangyuan Pharmaceutical also saw declines exceeding 6%, while Shutaishen, Hite Bio, Shouyao Holdings, and Wanbangde dropped over 5% [2] Group 2 - The MACD golden cross signal has formed, indicating a positive trend for certain stocks [3]

Group 1 - The 6G concept is gaining initial strength in the market, with several companies experiencing significant stock price increases [1] - Companies such as Sanwei Communication, China Satellite, and Tongyu Communication have reached their daily price limit [1] - Other companies including Chuangyuan Xinke, Xinke Mobile-U, China Satellite Communications, Xinwei Communication, Jinxin Nuo, and Shenglu Communication also saw stock price increases [1]

创新药概念股短线走弱，南新制药跌超12%，热景生物跌超9%，舒泰神、苑东生物、美迪西跟跌。 ...

Group 1 - The A-share chemical pharmaceutical sector experienced a sharp rise followed by a decline on August 28, with notable drops in stocks such as Nanxin Pharmaceutical and Rejing Bio, both falling over 10% [1] - Other companies in the sector, including Shutaishen, Yuandong Bio, Kanghong Pharmaceutical, and Kangyuan Pharmaceutical, also saw declines [1]

Group 1 - The innovative drug concept stocks have weakened in the short term, with Nanxin Pharmaceutical dropping over 10% [1] - Hotgen Biotech has seen a decline of over 8% [1] - Other companies such as Shutai Shen, Yuandong Biotech, and Medici have also experienced significant declines [1]